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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT00528502
Other study ID # 2006-0147
Secondary ID
Status Withdrawn
Phase Phase 3
First received September 11, 2007
Last updated December 5, 2012
Start date June 2006
Est. completion date January 2008

Study information

Verified date December 2012
Source M.D. Anderson Cancer Center
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

Primary Objective:

1. To determine if the application of lidocaine to the airway will obtund or abolish the laryngeal reflexes. This in turn will lead to a quiescent controlled surgical field.


Description:

Lidocaine is a local anesthetic that causes numbness to the throat when misted into the air. This numbness in the throat should stop the urge to clear the throat in the middle of the operation. Therefore, this should stop the interruptions during the surgery.

If you agree to take part in this study, you will be randomly assigned (as in the toss of a coin) to one of 2 groups. Participants in Group 1 will receive the saline mist. This will moisturize and soothe the throat. Participants in Group 2 will receive the lidocaine mist. Lidocaine or saline is misted into the air that you breathe during the surgery. You and your surgeon will not be told which group you were assigned to. At the end of the surgery, your surgeon will answer some questions to help determine if the use of lidocaine or saline is beneficial.

You will be considered off-study once you are sent to the recovery room after surgery.

This is an investigational study. Lidocaine is FDA-approved and commercially available for local anesthesia. If you are in the lidocaine or the saline group. Up to 105 patients will take part in this study. All will be enrolled at M. D. Anderson.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date January 2008
Est. primary completion date January 2008
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- All outpatients scheduled for MIPS at the ACB by Dr N Perrier, Dr D Evans and Dr JE Lee.

Exclusion Criteria:

- Patients who are excluded will be any who require elective endotracheal intubation as a preoperative decision by the anesthesia team. These patients will be those with sleep apnea, BMI>35, uncontrolled gastro esophageal reflux.

- Patients who have a history of allergy/hypersensitivity to lidocaine.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Lidocaine
Lidocaine is misted into the air that you breathe during the surgery.
Saline
Saline is misted into the air that you breathe during the surgery.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
M.D. Anderson Cancer Center

Outcome

Type Measure Description Time frame Safety issue
Primary Severity of Airway Interruption Assessment made by surgeon during minimally invasive parathyroidectomy surgery No
Primary Quality of Operative Field Assessment made by surgeon during minimally invasive parathyroidectomy surgery No
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